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# Class 2 for Lynch Syndrome Test Systems
- URL: https://www.fdaweb.com/class-2-for-lynch-syndrome-test-systems/
- Published: 2018-02-27T12:00:00.000Z
- Updated: 2026-09-14T23:25:53.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5140852

*Federal Register* notice: FDA has classified Lynch syndrome test systems into Class 2 (special controls). The action is based on a Ventana Medical Systems *de novo* classification request for its Ventana MMR IHC Panel. The agency has named the generic device as Lynch syndrome test systems, which are identified as *in vitro* diagnostic tests for use with tumor tissue to identify previously diagnosed cancer patients at risk for having Lynch syndrome. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2018-02-27/pdf/2018-03924.pdf?ref=fdaweb.com).